The FDA will develop more standardized, streamlined and structured processes for reviewing new drugs, FDA commissioner Dr. Scott Gottlieb announced Tuesday. To do that, the agency will create a new group, the Office of Drug Evaluation Science, whose 52 members will assess drug efficacy and safety, explore how to use information technology and monitor how biomarkers are researched. The new group will take a more structured approach to data analysis, Gottlieb said. The data they study will come from the cloud, which could make them more numerous and more readily available. The office will begin its work with a structured review of data that examines the safety of new drugs. It will also evaluate biomarkers, bioinformatics and patient-reported outcomes.
The NIH distributed $446.2 million in SBIR/STTR awards in 2017, with every state except North and South Dakota receiving an award. Although California and Massachusetts had the most successful SBIR/STTR applications in 2017, accounting for roughly one-third of the total when combined, neither state ranked among the top 10 in success rate. NIH SBIR/STTR applications in Oregon (29 percent success rate), Vermont (25 percent success rate) and Wisconsin (23 percent success rate) were the most likely to be approved over the ten-year period from 2008 to 2017.
A Houston-based medical equipment rental company is expanding to Nashville with a planned 8,000-square-foot facility at Nashville International Airport. US Med-Equip plans to employ 15 to 20 people when the facility’s build-out is complete in about 45 days, Chief Development Officer Greg Salario said. The hub will service 11 of the company’s 26 locations, including Memphis, Louisville, Birmingham, St. Louis and Jackson, Mississippi. The company expects to invest $15 million to $20 million in Nashville during the next five years, part of a broader $50 million investment US Med-Equip is making into the mid-America region.
Germany’s Boehringer Ingelheim has been working to boost its research capabilities in central nervous system (CNS) disorders, making moves over the past year aimed specifically at adding compounds to its pipeline to address Alzheimer’s disease (AD), schizophrenia and depression. Now it’s teaming up with Vanderbilt University to develop novel small molecules that modulate brain circuits. BI announced that the pact with Vanderbilt—which follows four cancer-focused research partnerships the two already have—will focus on compounds that target two different G-protein coupled receptors (GPCRs).
Cumberland Pharmaceuticals and Clinigen Group have announced that a new study shows that subcutaneous amifostine may postpone the onset of acute esophagitis in a subset of patients with small cell lung carcinoma receiving concurrent chemoradiotherapy. Acute esophageal inflammation has been described as a dose-limiting effect for those with stage 3 small cell lung carcinoma. Cumberland markets amifostine in the U.S. under the name Ethyol® on behalf of Clinigen Group.